Short‐Term Outcomes from a Randomized Screening Phase II Non‐inferiority Trial Comparing Omentectomy and Omentum Preservation for Locally Advanced Gastric Cancer: the TOP‐G Trial
- 10 February 2021
- journal article
- research article
- Published by Wiley in World Journal of Surgery
- Vol. 45 (6), 1803-1811
- https://doi.org/10.1007/s00268-021-05988-7
Abstract
Background Omentectomy is considered an essential part of curative gastrectomy for locally advanced gastric cancer (GC), albeit without solid evidence. We conducted a randomized phase II trial (the TOP-G trial) comparing omentectomy and omentum preservation for gastric cancer. This report describes the short-term findings regarding the trial’s secondary endpoints. Methods The trial protocol was submitted to the University Hospital Medical Information Network Clinical Trials Registry (http://www.umin.ac.jp/ctr/: UMIN000005421). The key eligibility criteria were histologically confirmed cT2–4a and N0–2 gastric adenocarcinoma. Short-term surgical outcomes, including morbidity and mortality, were compared between the omentectomy group (group A, control arm) and the omentum-preserving surgery group (group B, test arm). All procedures were performed via an open approach. Based on a non-inferiority margin of 7%, statistical power of 0.7, and type I error of 0.2, the sample size was set to 250 patients. Results A total of 251 patients were eligible and randomized (group A: 125 patients, group B: 126 patients) between April 2011 and October 2018. After excluding patients who had peritoneal metastasis or laparotomy history, safety outcomes were analyzed for 247 patients. Group A had a significantly longer median operation time (225 min vs. 204 min, p = 0.022) and tended to have greater median blood loss (260 mL vs. 210 mL p = 0.073). The incidences of morbidity were similar and < 10% in both groups (8% vs. 9%, p = 1.000). There was no mortality in either group. Conclusions Operative risk was generally similar between omentectomy and omentum-preserving surgery for locally advanced gastric cancer.This publication has 19 references indexed in Scilit:
- A Randomized Phase II Trial of Omentum-preserving Gastrectomy for Advanced Gastric CancerJapanese Journal of Clinical Oncology, 2012
- Ultrasonic Scalpel for Gastric Cancer Surgery: a Prospective Randomized StudyJournal of Gastrointestinal Surgery, 2012
- Omentum-preserving gastrectomy for advanced gastric cancer: a propensity-matched retrospective cohort studyGastric Cancer, 2012
- Japanese classification of gastric carcinoma: 3rd English editionGastric Cancer, 2011
- Omentum‐Preserving Gastrectomy for Early Gastric CancerWorld Journal of Surgery, 2008
- Extranodal metastasis is an indicator of poor prognosis in patients with gastric carcinomaBritish Journal of Surgery, 2006
- Insufficient ability of omental milky spots to prevent peritoneal tumor outgrowth supports omentectomy in minimal residual diseaseCancer Immunology, Immunotherapy, 2005
- Classification of Surgical ComplicationsAnnals of Surgery, 2004
- Quantitative detection of disseminated cancer cells in the greater omentum of gastric carcinoma patients with real-time RT-PCR: a comparison with peritoneal lavage cytologyGastric Cancer, 2002
- ON THE RADICAL OPERATION FOR CANCER OF THE PYLORUS: WITH ESPECIAL REFERENCE TO THE ADVANTAGES OF THE TWO-STAGE OPERATION AND TO THE QUESTION OF THE REMOVAL OF THE ASSOCIATED LYMPHATICSBMJ, 1910